1. National registry of thoracoamniotic shunting using a double-basket catheter: A post-marketing surveillance registry of 295 patients with fetal hydrothorax.
- Author
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Takahashi Y, Ishii K, Ishikawa H, Imai K, Baba K, and Sago H
- Subjects
- Humans, Female, Pregnancy, Adult, Catheters adverse effects, Product Surveillance, Postmarketing statistics & numerical data, Fetal Therapies methods, Fetal Therapies statistics & numerical data, Fetal Therapies instrumentation, Fetal Therapies adverse effects, Infant, Newborn, Fetal Diseases epidemiology, Fetal Diseases surgery, Registries statistics & numerical data, Hydrothorax surgery, Hydrothorax epidemiology, Hydrothorax etiology
- Abstract
Objective: We report on the 1-year outcomes of fetuses who underwent thoracoamniotic shunting (TAS) with a double-basket catheter for fetal hydrothorax (FHT) using a national post-marketing surveillance registry., Methods: This surveillance study was conducted for cases enrolled between 2011 and 2019. Preoperative, operative, and postoperative findings and outcomes had to be reported through the national surveillance website., Results: Forty-three institutes enrolled 295 patients. In 60 patients, associated abnormalities were diagnosed after birth. Among the 235 patients with isolated hydrothorax, the survival rate at 1 year of age was 70.5%. Among these patients, 89% did not require oxygen or other respiratory support. The 1-year survival rate in complicated cases was 27%. Trisomy 21 was the most common associated problem (40%). Catheter associated problems, including dislocation (25%), obstruction (24%), and preterm rupture of the membranes (6%) were observed, but there were no severe maternal complications. TAS before 29.5 weeks of gestation (odds ratio [OR] 0.16) and skin edema and ascites (OR 0.06) were risk factors for death at one year, whereas appropriate shunt location for >28 days (OR 4.2) was a protective factor., Conclusion: We report a favorable survival rate in fetuses with isolated FHT treated with this double-basket catheter., (© 2024 John Wiley & Sons Ltd.)
- Published
- 2024
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